Chicago, Illinois -- The research team of Project PrEPare -- a Chicago-based pre-exposure prophylaxis (PrEP) trial being conducted through the Adolescent Trials Network for HIV/AIDS Interventions (ATN) -- is encouraged by recent data demonstrating that antiretroviral drugs can prevent HIV infection among men who have sex with men and transgendered persons.

The Pre-exposure Prophylaxis Initiative, or iPrEX, was the first clinical trial of its kind. This study showed that the antiretroviral drug Truvada, when offered as a component of a comprehensive prevention package that includes condoms, counseling, and regular HIV/STI screening, was associated with a 44% reduction in HIV infections in participants who took it compared to those who took placebo. Additionally, a nearly 73 percent reduction in infections was seen in participants who took the study drug more than 90 percent of the time.

"Considering the fact that men who have sex with men continue to be disproportionately affected by the HIV epidemic here in Chicago, we are extremely excited to have data to support a new addition to the 'toolbox' of HIV prevention interventions currently available to us," said Sybil Hosek, PhD, Principal Investigator of Project PrEPare. "We must remember, however, that this is only the first step in determining whether or not PrEP could become a part of a comprehensive HIV prevention package in the real world."

The iPrEx study followed 2,499 healthy, "high-risk" gay men, transgender women, and other men who have sex with men from 11 sites located in Peru, Ecuador, Brazil, South Africa, Thailand, and the United States. Participants were randomly assigned to take either one tablet of Truvada (a combination of tenofovir and emtricitabine) or a placebo once a day. Less than 10 percent of the study sample was from the U.S., however, and even fewer represent the ethnic/racial backgrounds of MSM most severely impacted by HIV in this country -- Black MSM.

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"Since Truvada is already available and is used as a treatment for HIV infection, it is imperative that we educate our communities about the encouraging results of this study but caution high-risk individuals about its limitations," said Margo Bell, MD, Co-Principal Investigator of Project PrEPare. "We don't want people, especially our young people, getting the idea that it's as simple as taking a pill a day to prevent HIV. It is just not that simple."

Project PrEPare is designed to explore the acceptability and feasibility of a PrEP trial among young men who have sex with men in Chicago. The study is primarily funded through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, with additional support from the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH). Project PrEPare began enrolling at Chicago's CORE Center and the Howard Brown Health Center in November 2009 and was nearly 66 percent enrolled upon the release of the iPrEx data.

"Moving forward, it will be critical that we get to some of the unanswered questions around the use of PrEP among young MSM in the U.S. through studies like Project PrEPare," said Project Director Keith Green, MSW. "We owe it to our study participants and the Chicagoland YMSM community at large to provide them with as much information as we can about this new prevention technology, so that they can make informed decisions about their health and safety."

A community forum to discuss the iPrEX data and its potential impact on the future directon of Project PrEPare will take place in the Michael Leppen Theater at the Center on Halsted, 3656 N. Halsted, on Wednesday, December 15th 2010 from 6:30-8:30pm. The discussion will be co-facilitated by Jim Pickett, Director of Advocacy for the AIDS Foundation of Chicago and Chair of the International Rectal Microbicide Advocates.

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